MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS TOUCH DEVICE & POWER SUP; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66801281

Device Problem Device Handling Problem (3265)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/14/2022

Event Type  Injury  

Event Description

It was reported that, during wound therapy, the patient experienced vein bleeding while using a renasys touch device.The device was used in exposed areas of the intestinal tract in spite of the instructions for use indicating it should not be applied in such circumstances.This adverse event was treated by performing hemostasis and by discontinuing npwt.Treatment with gauze was applied instead.Patient's current health status is unknown.

Manufacturer Narrative

H3, h6: the device was returned for evaluation.A visual and functional evaluation found no faults the device performed within expected parameters, confirming this event is not related to a device malfunction.A documentation review was conducted, historical data, has revealed no manufacturing related concerns or escalation in regard to this event type, and no open corrective actions.The manufacturing records contain no contributory factors that could have caused or contributed to the event which was released according to the final product specification.The associated risk files mitigate the event and further delineated within the instruction for use which contains warnings specifically advising against using this device in such circumstances.Medical review concluded, based on the information provided, this report is due to improper use of the device.The device was used in exposed areas of the intestinal tract despite its contraindication the instructions for use indicating it should not be applied in such circumstances.According to the report, the device was left in place for approximately four hours, and this adverse event was treated by performing hemostasis and discontinuing the npwt and an application of gauze.The impact to the patient beyond that which has already been reported cannot be confirmed no concluded.Should any additional relevant medical information be provided, this case would be re-assessed.As detailed in the medical review and the ifu the probable cause for the event is misuse.No manufacturing quality concerns have been observed, therefore no corrective actions are deemed necessary, smith and nephew will continue to monitor for adverse trends.

• Brand Name: RENASYS TOUCH DEVICE & POWER SUP
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 101 hessle road; hull east riding of yorkshire HU3 2-BN ; UK HU3 2BN
• MDR Report Key: 14288763
• MDR Text Key: 290811574
• Report Number: 8043484-2022-00141
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 05000223494476
• UDI-Public: 5000223494476
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K181204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66801281
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention